Can you introduce HighTide Therapeutics and present key highlights from 2022?

HighTide was founded in 2011. We are a globally integrated biotech company with operations in the US and China. Currently, we are focusing on the development of multifunctional therapeutics for chronic diseases, including metabolic disorders and gastrointestinal diseases.

This period has certainly been challenging for the biotech industry, but we are doing remarkably well. In 2022, we finished enrollment in a Phase 2 Type 2 diabetes program, initiated our Phase 2b NASH program in the US, and had a very successful end-of-Phase 2 meeting with the FDA for the treatment of a rare liver disease called primary sclerosing cholangitis. We increased our headcount by 30% and added three senior vice presidents based in the US. Another crucial highlight was the raise of $107 million in a Series C/C+ Financing. In addition, we also closed around $60 million in late 2020. The fund in the bank provides us a solid financial support to carry us through 2025.

What is the latest news regarding the clinical development of HTD1801?

HTD1801 is a first-in-class new molecular entity. It is our lead drug candidate and is currently in clinical development for the treatment of type 2 diabetes (T2DM), non-alcoholic steatohepatitis (NASH), severe hypertriglyceridemia (SHTG), and primary sclerosing cholangitis (PSC). The composition of matter patents goes until 2035 before any regulatory extension. This compound has unique properties for chronic disease.

We are currently advancing the program on three fronts. One is a type 2 diabetes program in China, where we will be initiating Phase 3 trials in 2023. The other program is NASH; we expect to finish the enrollment of the Phase 2b study by the end of this year. Finally, we are evaluating HTD1801 in SHTG. All of these programs are interrelated as 50% of people with type 2 diabetes have elevated triglycerides, and 30-40% have fatty liver, a proportion of those patients progress to NASH. We are also working with regulatory agencies about the PSC rare disease program, and the FDA gave us the go-ahead for the phase 3 trial. This is the status of our lead asset and the development plan for 2023.

What is driving the need for medical solutions against nonalcoholic fatty liver disease (NAFLD) and how do you see the blockbuster potential of NASH?

Nonalcoholic fatty liver disease (NAFLD) is the most common form of chronic liver disease in the US, and nonalcoholic steatohepatitis (NASH) is the most severe form of NAFLD.

NASH is a slow-progressing disease, and is becoming the number one reason for liver transplantation. I think that NASH drug development in the next decade will be like diabetes drug development in the 1990s. In the last 5-10 years, there was a first wave of NASH drug development, many companies jumped on it, however, many flopped. Today, as more robust drug candidates are emerging, I am willing to bet that we will have the first NASH drug approved in 2023. Once there is a drug on the market, there will be more public awareness of the condition. This market will have 8-10 blockbuster drugs in the next decade. Multifunctional drugs will play a major role, as we need a backbone therapy, and this is where HTD1801 positions itself.

How do you view the main opportunities for clinical-stage firms in the US?

Undoubtedly, 2022 was harsh on biotech companies. In 2023, there will be more partnerships and a strengthening of the sector. People are talking about the use of real-world data, venture capital firms are more interested in metabolic and chronic diseases. The more we learn about AI and big data, the more efficient the drug discovery and development process will be. There are a lot of drug candidates out there, and how to develop them, engineer them, and get them approved is exciting.

What is going to make HighTide a great story in the coming months?

We are well-funded and pushing our clinical programs as fast as possible. I anticipate several milestones this year, which should attract investors, collaborators, and partners. In addition, we plan to push one or two new programs into clinical development this year to enhance our pipeline. Prestigious investors follow us so as we get more funding, we will be in ever better financial health to become a commercially successful company.